Appendix Information on Recommended Measures Child Health Questionnaire

The CHQ, designed to measure the physical and psychological well-being of children 5 years or older, has several forms related to the age of the child and who completes the questionnaire [67], There are three parent forms and a form to be completed by children aged 10 years or older (87 items), The questionnaires tap 14 concepts related to health and well-being, Item responses are on 4- to 6-point scales, Scale scores are transformed to range from 0 to 100, Higher scores reflect better health, Physical and psychological summary measures can be calculated, In addition to self-completion by child or parent, the forms may be administered in person or over the phone,

Psychometric performance is adequate in terms of internal consistency and test-retest reliability as well as content, criterion, and construct validity [67, 95, 139, 140], The measure has been translated, adapted, and revalidated for use in a number of countries [68], To obtain a manual and the questionnaire, contact J,M, Landgraf (Fax: +1-617-3757801),

European Organization for Research and Treatment of Cancer

The EORTC is a cancer-specific questionnaire that has a core component to be used in conjunction with one of a number of modules reflecting different sites of cancer [1, 2], The core questionnaire EORTC QLQ-C30 contains 30 items that form seven subscales: physical functioning, role functioning, common physical symptoms of cancer and its treatment, emotional functioning, role functioning, financial impact, and overall perceived health status and global QoL. Most items are scored on a 4-point scale ranging from "not at all" to "very much"; the physical and role functioning subscales are scored dichotomously, and the global questions on health status and QoL have been expanded to a 7-point scale. The time frame of the questions is the past week. For the functional and global subscale, a higher score represents a higher QoL, whereas for the symptom subscales the reverse is true. The site-specific modules provide more detailed information on symptoms related to the specific tumor site and may tap additional areas.

A variety of studies attest to the adequate reliability and validity of the questionnaire. In particular, the symptom scales have shown sensitivity to clinical change. The questionnaire was developed by an international group of researchers. In consequence, careful attention was given to ensuring that the questions had a similar meaning across languages and cultures. The modules for colorectal and prostate cancer are forthcoming [120].

Fecal Incontinence Quality of Life Scale

The FIQL scale is a symptom-specific measure of QoL developed from input from both patients and caregivers [108]. It is composed of 29 items that form four scales: lifestyle (10), coping/behavior (9), depression/self-perception (7), and embarrassment (3). Each item has four to six response categories. Scale scores are the mean response to all items in a scale. A total score was not calculated by the developer, but one has been used by Jess and colleagues [52].

Confirmatory factor analysis supported use of four scales. Internal consistency estimates were 0.80 or greater for each scale. Mean scale scores of a test-retest situation were not significantly different, but agreement was not measured directly. Each scale was able to differentiate between a group of individuals with fecal incontinence and patients with other gastrointestinal problems. Convergent validity was demonstrated by significant correlations with selected scales of the SF-36. A Danish version of the measure has been developed, and the psychometric evaluation of this version produced results similar to those of the developers except that total scores were included [52]. The measure is included as an appendix in the original article [108].

Functional Assessment of Cancer Therapy

The FACT-G is a general measure of QoL for use with people who have cancer. It is the core instrument of the measurement system [16, 17]. FACT-G contains 29 items that constitute five subscales: physical well-being, social/family well-being, relationship with doctor, emotional well-being, and functional well-being. Items are scored on a 5-point scale and summed to provide subscale and total scores. The five subscales are included in the site-specific scales, and each has an additional subscale containing items related to the cancer, its symptoms, or its treatment. A number of site-specific scales, including the FACT-C (colorectal) [135] and the FACT-P (prostate), [33] are available.

Extensive documentation exists on the psychometric properties of FACT-G and its various versions. A manual is available [16] and the scales have been translated and adapted for use in different countries and cultures [11]. For information about using the measurement system, see http://www.facit.org.

Gastroesophageal Reflux Disease - Health-Related Quality of Life

The GERD-HRQL is a measure of symptom severity for use with individuals who have GERD [130, 133]. Ten common and distressing symptoms are listed. The first six are ordered in terms of their relative annoyance to patients. Each symptom is rated on a 6-point categorical scale that ranges from 0 (no symptoms) to 5 (symptoms are incapacitating - unable to do daily activities). The overall score is from 0 to 50, but there is an additional question asking about satisfaction with the patient's "present condition."

No data were found on test-retest reliability, but the developers reported evidence supporting construct validity and responsiveness to clinical change. When patients were grouped according to their level of satisfaction with their present condition, the median scores discriminated between those who were satisfied and those who were not. Sensitivity to the effects of both medical and surgical treatment provided preliminary evidence of responsiveness. A copy of the scale is provided in the article by Valanovich [130].

Gastrointestinal Quality of Life Index

The GIQLI is a self-reported, system-specific measure designed for use with people who have different gastrointestinal disorders [35, 37, 38]. The 36 items, reflecting physical, emotional, and social function as well as typical gastrointestinal symptoms, are each scored on a 5-point scale. Items are summed to produce a total score ranging from 0 to 176, with higher scores denoting better QoL. The measure was developed in German and English. French and Spanish GIQLI versions have been validated [100, 117].

A comprehensive process of development assured content validity. The internal consistency estimates were high, suggesting that the measure reflects an underlying dimension, QoL. Test-retest reliability was demonstrated in clinically stable patients (ICC = 0.92). Correlations between the GIQLI and appropriate measures supported construct validity. Scores on the measure were also able to differentiate groups of gastrointestinal patients with different levels of function, as well as between those with gastrointestinal disease and those who were ostensibly normal. Responsiveness is obviously highest in gastroesophageal disorders, but the GIQLI has also been used with variable responsiveness in other abdominal operations [14, 19, 42, 65, 73]. The GIQLI is available on the Quality of Life Database developed by the nonprofit Mapi Research Institute. This database can be found at http://www.qolid.org.

Gastrointestinal Symptom Rating Scale

The GSRS is a clinical symptom rating scale originally designed for patients with irritable bowel syndrome and peptic ulcer disease [122]. It has subsequently been evaluated in patients with GERD [105, 123]. GSRS for use with GERD patients contains 15 items, each assessed on a 1-point to 7-point scale, with 7 representing extreme discomfort. The items combine into five syndromes labeled reflux, abdominal pain, indigestion, diarrhea, and constipation. Mean scores are calculated from the items in each syndrome. The measure may be administered as a self-report or by an interviewer. The GSRS has been used in UK, Scandinavian, and US populations. It demonstrates acceptable reliability, both internal consistency and stability, evidence of construct and discriminative validity, as well as responsiveness to change. A copy of the US version of the GSRS is included in the article by Revicki and colleagues [105].

Impact of Weight on Quality of Life-Lite

The IWQOL-Lite is a 31-item version of its parent instrument, the Impact of Weight on Quality of Life (IWQOL) questionnaire [63, 64]. Data collected from 996 obese patients and controls were used to develop the shorter measure [61]. Items were selected by predefined criteria. The items are divided among five scales: physical function (11), self-esteem (7), public distress (5), sexual life (4), and work (4). Each item is scored on a 5-point scale (always true - never true). Lower scores indicate higher QoL. Exploratory factor analysis supported the scale structure.

Based on data from the cross-validation sample (n =991), individual scales and the total IWQOL-Lite questionnaire demonstrated strong measurement properties. Confirmatory factor analyses confirmed the adequacy of the scale structure. Internal consistency coefficients (alphas) ranged from 0.90 to 0.94 across the scales, with an overall alpha coefficient of 0.96. Correlations between appropriate IWQOL-Lite scales and appropriate standardized measures upheld construct validity. The measure also demonstrated the ability to differentiate between adjacent groups of obese individuals. Changes to scales over time correlated with changes in weight, verifying responsiveness to change. According to the authors, the IWQOL-Lite has been translated and pilot-tested for use in 23 countries [62]. To obtain further information, contact R.L. Kolotkin (1004 Norwood Avenue, Durham, NC, USA; e-mail: [email protected]).

Pediatric Quality of Life Inventory

The PedsQL is a generic instrument developed in modular format for measuring health-related QoL in children and adolescents aged 2-18 years [128, 129]. The PedsQL 4.0 Generic Core Scales assess functioning in four areas: physical (8), emotional (5), social (5), and school (5). Both parent and child versions of the inventory are available and use different response sets for scoring items. For parents and children aged 8-18, the inventory is generally self-administered, and for children aged 5-7 it is normally interviewer administered. Modules are available for a number of pediatric conditions, including cancer [127]. Higher PedsQL scores indicate better QoL.

The inventory has been extensively tested for reliability and validity. Internal consistency is adequate for group comparisons and the measure correlated moderately with measures of morbidity and illness burden as well as distinguishing between healthy children and those with a variety of acute and chronic illnesses. It is available in English and Spanish. Further information about the PedsQL is available at http://www.pedsql.org. To order the PedsQL, contact Caroline Anfray at the Mapi Research Institute (e-mail: [email protected]).

Psychological General Well-Being Index

The PGWB index was developed as a measure of subjective well-being or distress [29]. This self-administered index contains 22 items, reflecting both positive and negative affect. These are divided into six dimensions: anxiety (5), depressed mood (3), positive well-being (4), self-control (3), general health (3), and vitality (4). Each item is scored on a 6-category scale (0-5 or 1- 6). The dimension scores combine for a total score ranging from 0-110 or 22-132.

Extensive tests of reliability and validity have been conducted, most often on the original version of the measure that contained 68 items and was referred to as the General Well-Being Schedule. These psychometric tests were carried out in a variety of normal populations and patient samples. Many have been reviewed by Dupuy [29]. Internal consistency estimates have most often been between 0.70 and 0.90, and test-retest reliability coefficients have ranged from moderate to strong. Construct validity has been shown by moderately strong correlations with a number of depression scales. Correlations with stressful life events and the use of health services were lower. Norms for the PSGWB index have been described for the Swedish population [25]. When used in a trial of patients with reflux disease, estimates of internal consistency were above 0.92 and decreased symptoms corresponded to an increase in PGWB scores [91]. Concurrent validity has also been confirmed in a variety of studies [85].

Quality of Life in Reflux and Dyspepsia Questionnaire

The QOLRAD is a disease-specific QoL questionnaire designed to address the health concerns of people with GERD or dyspepsia [146]. The measure contains 25 items encompassing five domains of importance to patients: emotional distress, sleep disturbance, eating and drinking issues, physical/social functioning, and vitality. Each item is scored on a 7-point scale and domain scores are calculated by averaging the item scores in that domain.

Good reliability in terms of both internal consistence and stability has been reported [123, 146]. Content, convergent, and discriminant validity as well as responsiveness to clinical change have been carefully documented, and results support the use of the measure in clinical studies [123, 146]. The measure was developed in English and French. For information on how to obtain the measure, contact Ingula Wiklund (Quality of Life Research, Astra Hassle AB, 431 83 MoIndal, Sweden).

Short Form 36

The SF-36 is a generic measure of perceived health status that incorporates behavioral functioning, subjective well-being, and perceptions of health by assessing eight health concepts: limitations in physical activities due to health problems, limitations in role activities due to physical health problems, pain, limitations in social activities due to health problems, general mental health, limitations in usual role activities due to, emotional problems, vitality (energy and fatigue), and general health perceptions [138]. The questionnaire is made up of 36 items that are divided into eight scales. The scores on all scales range from 0 to 100, with higher scores reflecting better health. The SF-36 takes 10-15 min to complete. It can be self-administered or used by a trained interviewer in person or over the telephone.

Reliability has been demonstrated, as have content, criterion, and construct validity [58, 79, 80, 138] and responsiveness to clinical change [58]. Recently, a method of scoring two components, physical and mental health, has been developed. Each component has been standardized to have a mean of 50 and a standard deviation of 10 [137]. There is also an acute version of the SF-36 that uses a 1-week recall, making it useful when treatment effects occur rapidly. As part of an international initiative that used a standard protocol, the SF-36 has been translated, culturally adapted, and revalidated in more than 50 languages. Norms for many countries are available [51].

For further information about the SF-36 and instructions for use, visit the SF-36 Web site (http://www.sf-36.com or http://www.qlmed.org/mot). The IQOLA Web site (http://www.iqola.org) provides information about the international project, and information on the availability of the translations can be found on the SF-36 Web site.

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